The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.

Dasatinib 140 mg QD

Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.

Dasatinib 50 mg BID

Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 70 mg BID

Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All participants randomized to a treatment arm are summarized.

Reporting Groups

Description

Dasatinib 100 mg QD

Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.

Dasatinib 140 mg QD

Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.

Dasatinib 50 mg BID

Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 70 mg BID

Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Total

Total of all reporting groups

Baseline Measures

Dasatinib 100 mg QD

Dasatinib 140 mg QD

Dasatinib 50 mg BID

Dasatinib 70 mg BID

Total

Overall Participants Analyzed [Units: Participants]

167

167

168

168

670

Age, Customized [Units: Participants]

Less than, equal to (<=) 65 years

121

128

130

125

504

Greater than (>) 65 years

46

39

38

43

166

Gender [Units: Participants]

Female

83

97

83

91

354

Male

84

70

85

77

316

Imatinib Status [1] [Units: Participants]

Primary Resistance to Imatinib

75

78

88

81

322

Acquired Resistance to Imatinib

49

45

36

45

175

Intolerant to Imatinib

43

44

44

42

173

[1]

Primary Resistance: no decrease in white blood cell (WBC) count after ≥ 4 weeks imatinib or not achieved a complete hematologic response (CHR) after 3 months, a major cytogenetic response (MCyR) after 6 months, or a complete cytogenetic response (CCyR) after 12 months. Acquired resistance: achieved MCyR and no longer met the criteria for MCyR. Intolerance: Grade ≥ 3 toxicity considered at least possibly related to imatinib at a dose of ≤ 400 mg/day which led to discontinuation of therapy; tolerated the dose of 400 mg but did not achieve a CCyR and subsequently did not tolerate doses ≥ 600 mg.

Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up [ Time Frame: 24 months ]

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up [ Time Frame: Baseline to 30 days post last dose, up to 24 months ]

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up [ Time Frame: Baseline to 30 days post last dose, up to 7 years (study closure July 2014) ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.